RR: Vital USA Respiratory Rate Validation In Adults

• Sponsor: Vital USA, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04292639
• Collaborator: Clinimark, LLC (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Days): 3
• Patients Per Site Per Month: 202.9

Study Details

Study Description

Brief Summary

Vital USA is dedicated to developing and applying innovative electronic medical solutions that improve patient care in multiple clinical settings. Vital USA is a manufacturer of a multi-parameter patient monitor that is intended to be used in a variety of medical settings including hospitals, medical offices and patients' homes.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Complication	Device: The Vital Detect Pulse Oximeter	N/A

Detailed Description

Purpose of Clinical Investigation Respiratory Rate is an important physiological measurement in the healthcare setting. End Tidal Carbon Dioxide (EtCO2) is considered to be the highest level of safety and accuracy in Respiratory Rate monitoring by the American Society of Anesthesiology and the American Association of Respiratory Care.

The purpose of this study was to conduct a Respiratory Rate accuracy validation comparing the Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda).

Respiratory Rate is an important physiological measurement in the healthcare setting. End Tidal Carbon Dioxide (EtCO2) is considered to be the highest level of safety and accuracy in Respiratory Rate monitoring by the American Society of Anesthesiology and the American Association of Respiratory Care.

The purpose of this study was to conduct a Respiratory Rate accuracy validation comparing the Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda).

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The Vital Detect is a noninvasive device designed for spot-checking physiological parameters, such as Noninvasive Blood Pressure, Oxygen Saturation, Pulse Rate, Body Temperature, and Respiratory Rate. This device is a finger-cuff technology which is applicable for use at-home or in healthcare facilities in/on individuals 18 years of age and older. It may be used by the individual themselves or an operator. The Vital Detect is not intended for continuous monitoring or for use with high frequency surgical equipment. It is non transit-operable. The Vital USA Vital Detect is composed of a sensor head mounted on a base connected to a phone or computer via Vital Detect App which is free to download.The Vital Detect is a noninvasive device designed for spot-checking physiological parameters, such as Noninvasive Blood Pressure, Oxygen Saturation, Pulse Rate, Body Temperature, and Respiratory Rate. This device is a finger-cuff technology which is applicable for use at-home or in healthcare facilities in/on individuals 18 years of age and older. It may be used by the individual themselves or an operator. The Vital Detect is not intended for continuous monitoring or for use with high frequency surgical equipment. It is non transit-operable. The Vital USA Vital Detect is composed of a sensor head mounted on a base connected to a phone or computer via Vital Detect App which is free to download.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Final Test Report for Vital USA Respiratory Rate Validation In Adults
• Actual Study Start Date: Dec 17, 2019
• Actual Primary Completion Date: Dec 20, 2019
• Actual Study Completion Date: Dec 20, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Respiratory Rate The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Vital USA Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda). This report documents exclusively the results of the Respiratory Rate accuracy performance for the Vital USA Vital Detect.

Device: The Vital Detect Pulse Oximeter; The Vital Detect is a noninvasive device designed for spot-checking physiological parameters, such as Noninvasive Blood Pressure, Oxygen Saturation, Pulse Rate, Body Temperature, and Respiratory Rate. This device is a finger-cuff technology which is applicable for use at-home or in healthcare facilities in/on individuals 18 years of age and older. It may be used by the individual themselves or an operator. The Vital Detect is not intended for continuous monitoring or for use with high frequency surgical equipment. It is non transit-operable. The Vital USA Vital Detect is composed of a sensor head mounted on a base connected to a phone or computer via Vital Detect App which is free to download.; Other Names: VitalDetect

Outcome Measures

Primary Outcome Measures

1. Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor. [20 Seconds]

   The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).The endpoint of interest was accuracy as measured by the Accuracy root-mean-square (ARMS) difference between the Device Under Test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 52 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject must have the ability to understand and provide written informed consent

• Subject is adult over 18 years of age

• Subject must be willing and able to comply with study procedures and duration

• Subject is a non-smoker

• Male or female of any race

Exclusion Criteria:

Subject is considered as being morbidly obese (defined as BMI >39.5)

• Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)

• Subjects with known respiratory conditions such as:

• uncontrolled / severe asthma,

• flu,

• pneumonia / bronchitis,

• shortness of breath / respiratory distress,

• respiratory or lung surgery,

• emphysema, COPD, lung disease

• Subjects with self-reported heart or cardiovascular conditions such as:

• have had cardiovascular surgery

• Chest pain (angina)

• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia

• previous heart attack

• blocked artery

• unexplained shortness of breath

• congestive heart failure (CHF)

• history of stroke

• transient ischemic attack

• carotid artery disease

• myocardial ischemia

• myocardial infarction

• cardiomyopathy

• Self-reported health conditions as identified in the Health Assessment Form

• diabetes,

• uncontrolled thyroid disease,

• kidney disease / chronic renal impairment,

• history of seizures (except childhood febrile seizures),

• epilepsy,

• history of unexplained syncope,

• recent history of frequent migraine headaches,

• recent head injury within the last 2 months,

• Cancer / chemotherapy

• Other known health condition, should be considered upon disclosure in health assessment form

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinimark Laboratory Services	Louisville	Colorado	United States	80027

Sponsors and Collaborators

• Vital USA, Inc.
• Clinimark, LLC

Investigators

• Principal Investigator: Arthur Cabrera, MD, Clinimark, LLC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 29, 2019

More Information

Publications

None provided.

• Responsible Party: Vital USA, Inc.
• ClinicalTrials.gov Identifier: NCT04292639
• Other Study ID Numbers: PR 2019-326
• First Posted: Mar 3, 2020
• Last Update Posted: May 28, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Recruitment Details	The final study population consisted of 20 qualified healthy subjects, 10 males and 10 females, ranging in age from 18 to 52 yrs of any racial / ethnic background. Each subject understood the study and provided consent for participation by signing the Independent Review Board (IRB) approved Informed Consent Form prior to start of the test.
Pre-assignment Detail	The subjects were healthy showing no evidence of significant medical problems as indicated by satisfactorily completing the health assessment form. Eligible subjects needed to meet all of the inclusion criteria and none of the exclusion criteria for participation.

Arm/Group Title	Respiratory Rate
Arm/Group Description	The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Vital USA Vital Detect to an FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda). This report documents exclusively the results of the Respiratory Rate accuracy performance for the Vital USA Vital Detect.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Respiratory Rate
Arm/Group Description	This study was a comparative, single-center, non-randomized, parallel study, conducted on 20 subjects. The acceptance criteria in this study used a comparison of the Vital USA Vital Detect to a reference Respiratory Rate EtCO2 monitor. Testing was conducted under normal office environment conditions.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.3 (10.5)
Sex: Female, Male (Count of Participants)
Female	10 50%
Male	10 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5%
Not Hispanic or Latino	19 95%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 15%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 5%
White	16 80%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%
Fitzpatrick Scale (Count of Participants)
Type I Pale White Skin Blue/Green Eyes	3 15%
Type II Fair Skin Blue Eyes	12 60%
Type III Darker White Skin	3 15%
Type IV Brown Skin	0 0%
Type V Dark Brown Skin	1 5%
Type VI Black Skin	1 5%
Weight (Lbs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Lbs]	151.9 (25.9)
Height (In) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [In]	67.3 (3.9)
BMI (lbs/sq.In.) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lbs/sq.In.]	23.5 (2.9)

Outcome Measures

1. Primary Outcome

Title	Respiratory Rate Accuracy Validation for the Vital USA Vital Detect Monitor.
Description	The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).The endpoint of interest was accuracy as measured by the Accuracy root-mean-square (ARMS) difference between the Device Under Test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods.
Time Frame	20 Seconds

Outcome Measure Data

Analysis Population Description

The final study population consisted of 20 qualified healthy subjects, 10 males and 10 females, ranging in age from 18 to 52 years and of any racial / ethnic background.

Arm/Group Title	Respiratory Rate
Arm/Group Description	The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).
Measure Participants	20
Mean (Standard Deviation) [Breaths/Min]	1.39 (1.39)

Adverse Events

Time Frame	on the study date
Adverse Event Reporting Description	There were no serious adverse events or serious adverse device effects during the study.
Arm/Group Title	Respiratory Rate
Arm/Group Description	The primary objective of this study was to compare the accuracy of device under test for the measurement of respiratory rate. The respiratory rate was measured simultaneously with EtCO2 (Reference) and the Vital USA Vital Detect monitor (Device Under Test).
All Cause Mortality
	Respiratory Rate
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Respiratory Rate
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Respiratory Rate
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

There were no serious adverse events or serious adverse device effects during the study. There were no observed device deficiencies that could have led to serious adverse device effects.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.